U.S. patent application number 10/927966 was filed with the patent office on 2006-03-02 for ultrasound catheter devices and methods.
This patent application is currently assigned to FlowCardia, Inc.. Invention is credited to Henry Nita, Jeff Sarge, Richard Spano.
Application Number | 20060047239 10/927966 |
Document ID | / |
Family ID | 35944364 |
Filed Date | 2006-03-02 |
United States Patent
Application |
20060047239 |
Kind Code |
A1 |
Nita; Henry ; et
al. |
March 2, 2006 |
Ultrasound catheter devices and methods
Abstract
Ultrasound catheter devices and methods provide enhanced
disruption of blood vessel obstructions. Generally, an ultrasound
catheter device includes an elongate flexible catheter body with
one or more lumens, an ultrasound transmission member extending
longitudinally through the catheter body lumen and a distal head
coupled with the transmission member and positioned adjacent the
distal end of the catheter body for disrupting occlusions. A
proximal housing of the catheter device may include one or more
features for dissipating heat from the ultrasound transmission
wire, such as a fluid inlet aperture for passage of fluid, use of
heat conductive materials in the proximal housing, surface features
to increase the housing's surface area, heat conductive members
disposed adjacent the transmission member and the like. Various
irrigation fluids may be used, such as cooled, oxygen
supersaturated or lubricious fluids.
Inventors: |
Nita; Henry; (Redwood City,
CA) ; Sarge; Jeff; (Fremont, CA) ; Spano;
Richard; (Gilroy, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
FlowCardia, Inc.
Sunnyvale
CA
|
Family ID: |
35944364 |
Appl. No.: |
10/927966 |
Filed: |
August 26, 2004 |
Current U.S.
Class: |
604/22 |
Current CPC
Class: |
A61B 17/2251 20130101;
A61B 2017/22014 20130101; A61B 17/22012 20130101; A61B 17/22004
20130101; A61B 2017/00477 20130101 |
Class at
Publication: |
604/022 |
International
Class: |
A61B 17/20 20060101
A61B017/20 |
Claims
1. An ultrasound catheter for disrupting occlusions in blood
vessels, the ultrasound catheter comprising: an elongate flexible
catheter body having a proximal end, a distal end and at least one
lumen; an ultrasound transmission member extending longitudinally
through the lumen of the catheter body and having a proximal end
and a distal end; a distal head coupled with the distal end of the
ultrasound transmission member and disposed adjacent the distal end
of the catheter body; a sonic connector coupled with the proximal
end of the ultrasound transmission member for coupling the
ultrasound transmission member with an ultrasound transducer
device; and a proximal housing coupled with the proximal end of the
catheter body and housing the sonic connector and a proximal
portion of the ultrasound transmission wire, wherein the proximal
housing includes at least one heat dissipation feature for
dissipating heat from the proximal portion of the ultrasound
transmission member.
2. An ultrasound catheter as in claim 1, wherein the heat
dissipation feature comprises one or more portions of the housing
constructed of a heat conductive material.
3. An ultrasound catheter as in claim 2, wherein the heat
conductive material is selected from the group consisting of metal,
polymer, glass, rubber and combinations thereof.
4. An ultrasound catheter as in claim 1 or 2, wherein the heat
dissipation feature comprises multiple surface features on the
housing to increase a surface area of the housing.
5. An ultrasound catheter as in claim 4, wherein the surface
features are selected from the group consisting of grooves,
notches, waves and dips.
6. An ultrasound catheter as in claim 1 or 2, wherein the heat
dissipation feature comprises at least one conductive material
disposed within the housing, at least partially encircling the
ultrasound transmission member, to conduct heat away from the
ultrasound transmission member.
7. An ultrasound catheter as in claim 6, wherein the conductive
material is disposed adjacent one or more vibration absorption
members surrounding the ultrasound transmission member.
8. An ultrasound catheter as in claim 7, wherein the at least one
conductive material comprises multiple separate conductive members
disposed between multiple vibration absorption members and at least
partially encircling the ultrasound transmission member.
9. An ultrasound catheter as in claim 6, wherein the conductive
material is arranged over one or more vibration absorption members
surrounding the ultrasound transmission member.
10. An ultrasound catheter as in claim 1, wherein the heat
dissipation feature comprises at least one fluid inlet for allowing
passage of one or more heat dissipating fluids into an inner cavity
of the housing.
11. An ultrasound catheter as in claim 10, wherein the inner cavity
of the housing is in fluid communication with the lumen of the
catheter body, such that fluid introduced into the inner cavity
passes through and out a distal end of the catheter body lumen.
12. An ultrasound catheter as in claim 10, wherein the inlet is
disposed along the housing such that the heat dissipating fluid(s)
passing through the inlet contact a proximal portion of the
ultrasound transmission member.
13. An ultrasound catheter as in claim 10, wherein the inlet is
disposed along the housing such that the heat dissipating fluid(s)
passing through the inlet contact at least one vibration absorption
member disposed over the ultrasound transmission member.
14. An ultrasound catheter as in claim 10 or 13, wherein the inlet
is disposed along the housing such that the heat dissipating
fluid(s) passing through the inlet contact the sonic connector and
a portion of the ultrasound transmission member.
15. An ultrasound catheter as in claim 10, further comprising a
refrigeration device coupled with the catheter for refrigerating a
fluid to be introduced through the fluid inlet.
16. An ultrasound catheter as in claim 10, further comprising a
guidewire tube extending through at least a portion of the catheter
body for allowing passage of a guidewire.
17. An ultrasound catheter as in claim 16, wherein a sidewall of
the guidewire tube includes a plurality of apertures for allowing
fluid introduced into the lumen of the catheter body to pass into
and through the guidewire tube.
18. An ultrasound catheter as in claim 1, wherein at least a
portion of the proximal housing comprises a material adapted to
change color when the temperature of the housing changes.
19. An ultrasound catheter as in claim 18, wherein the material
comprises a thermochromic pigment.
20. An ultrasound catheter as in claim 19, wherein the
thermochromic pigment changes from a first color to a second color
when the temperature of the housing reaches approximately
45.degree. Celsius and changes from the second color to the first
color when the temperature of the housing drops below approximately
45.degree. Celsius.
21. An ultrasound catheter for disrupting occlusions in blood
vessels, the ultrasound catheter comprising: an elongate flexible
catheter body having a proximal end, a distal end and at least one
lumen; an ultrasound transmission member extending longitudinally
through the lumen of the catheter body and having a proximal end
and a distal end; a distal head coupled with the distal end of the
ultrasound transmission member and disposed adjacent the distal end
of the catheter body; a sonic connector coupled with the proximal
end of the ultrasound transmission member for coupling the
ultrasound transmission member with an ultrasound transducer
device; a proximal housing coupled with the proximal end of the
catheter body and housing the sonic connector and a proximal
portion of the ultrasound transmission wire; and means for
dissipating heat from the ultrasound transmission member.
22. An ultrasound catheter as in claim 21, wherein the heat
dissipation means comprises one or more portions of the housing
constructed of a heat conductive material.
23. An ultrasound catheter as in claim 22, wherein the heat
conductive material is selected from the group consisting of metal,
polymer, glass, rubber and combinations thereof.
24. An ultrasound catheter as in claim 22, wherein the heat
dissipation means further comprises multiple surface features on
the housing to increase a surface area of the housing.
25. An ultrasound catheter as in claim 24, wherein the surface
features are selected from the group consisting of grooves,
notches, waves and dips.
26. An ultrasound catheter as in claim 21, wherein the heat
dissipation means comprises at least one conductive material
disposed within the housing, at least partially encircling the
ultrasound transmission member, to conduct heat away from the
ultrasound transmission member.
27. An ultrasound catheter as in claim 26, wherein the conductive
material is disposed adjacent one or more vibration absorption
members surrounding the ultrasound transmission member.
28. An ultrasound catheter as in claim 27, wherein the at least one
conductive material comprises multiple separate conductive members
disposed between multiple vibration absorption members and at least
partially encircling the ultrasound transmission member.
29. An ultrasound catheter as in claim 26, wherein the conductive
material is arranged over one or more vibration absorption members
surrounding the ultrasound transmission member.
30. An ultrasound catheter as in claim 21, wherein the heat
dissipation means comprises at least one fluid inlet for allowing
passage of one or more heat dissipating fluids into an inner cavity
of the housing.
31. An ultrasound catheter as in claim 30, wherein the inner cavity
of the housing is in fluid communication with the lumen of the
catheter body, such that fluid introduced into the inner cavity
passes through and out a distal end of the catheter body lumen.
32. An ultrasound catheter as in claim 30, wherein the inlet is
disposed along the housing such that the heat dissipating fluid(s)
passing through the inlet contact a proximal portion of the
ultrasound transmission member.
33. An ultrasound catheter as in claim 30, wherein the inlet is
disposed along the housing such that the heat dissipating fluid(s)
passing through the inlet contact at least one vibration absorption
member disposed over the ultrasound transmission member.
34. An ultrasound catheter as in claim 30 or 33, wherein the inlet
is disposed along the housing such that the heat dissipating
fluid(s) passing through the inlet contact the sonic connector and
a portion of the ultrasound transmission member.
35. An ultrasound catheter as in claim 30, further comprising a
refrigeration device coupled with the catheter for refrigerating a
fluid to be introduced through the fluid inlet.
36. An ultrasound catheter as in claim 30, further comprising a
guidewire tube extending through at least a portion of the catheter
body for allowing passage of a guidewire.
37. An ultrasound catheter as in claim 36, wherein a sidewall of
the guidewire tube includes a plurality of apertures for allowing
fluid introduced into the lumen of the catheter body to pass into
and through the guidewire tube.
38. An ultrasound catheter as in claim 21, wherein at least a
portion of the proximal housing comprises a material adapted to
change color when the temperature of the housing changes.
39. An ultrasound catheter as in claim 38, wherein the material
comprises a thermochromic pigment.
40. An ultrasound catheter as in claim 39, wherein the
thermochromic pigment changes from a first color to a second color
when the temperature of the housing reaches approximately
45.degree. Celsius and changes from the second color to the first
color when the temperature of the housing drops below approximately
45.degree. Celsius.
41. An ultrasound catheter system for disrupting occlusions in
blood vessels, the system comprising: an ultrasound catheter
device, comprising: an elongate flexible catheter body having a
proximal end, a distal end and at least one lumen; an ultrasound
transmission member extending longitudinally through the lumen of
the catheter body and having a proximal end and a distal end; a
distal head coupled with the distal end of the ultrasound
transmission member and disposed adjacent the distal end of the
catheter body; a sonic connector coupled with the proximal end of
the ultrasound transmission member for coupling the ultrasound
transmission member with an ultrasound transducer device; and a
proximal housing coupled with the proximal end of the catheter body
and housing the sonic connector and a proximal portion of the
ultrasound transmission wire, wherein the housing includes at least
one fluid inlet for allowing passage of one or more heat
dissipating fluids into an inner cavity of the housing; an
ultrasound generator removably coupled with the ultrasound catheter
device; and a fluid cooling device removably coupled with the
ultrasound catheter device for cooling the heat dissipating
fluid(s).
42. A system as in claim 41, wherein one or more portions of the
housing are constructed of a heat conductive material.
43. A system as in claim 42, wherein the heat conductive material
is selected from the group consisting of metal, polymer, glass,
rubber and combinations thereof.
44. A system as in claim 42, wherein the housing further comprises
multiple surface features to increase a surface area of the
housing.
45. A system as in claim 44, wherein the surface features are
selected from the group consisting of grooves, notches, waves and
dips.
46. A system as in claim 41, further comprising at least one
conductive material disposed within the housing, at least partially
encircling the ultrasound transmission member, to conduct heat away
from the ultrasound transmission member.
47. A system as in claim 46, wherein the conductive material is
disposed adjacent one or more vibration absorption members
surrounding the ultrasound transmission member.
48. A system as in claim 47, wherein the at least one conductive
material comprises multiple separate conductive members disposed
between multiple vibration absorption members and at least
partially encircling the ultrasound transmission member.
49. A system as in claim 46, wherein the conductive material is
arranged over one or more vibration absorption members surrounding
the ultrasound transmission member.
50. A system as in claim 41, wherein the inner cavity of the
housing is in fluid communication with the lumen of the catheter
body, such that fluid introduced into the inner cavity passes
through and out a distal end of the catheter body lumen.
51. A system as in claim 41, wherein the inlet is disposed along
the housing such that the heat dissipating fluid(s) passing through
the inlet contact a proximal portion of the ultrasound transmission
member.
52. A system as in claim 41, wherein the inlet is disposed along
the housing such that the heat dissipating fluid(s) passing through
the inlet contact at least one vibration absorption member disposed
over the ultrasound transmission member.
53. A system as in claim 41 or 52, wherein the inlet is disposed
along the housing such that the heat dissipating fluid(s) passing
through the inlet contact the sonic connector and a portion of the
ultrasound transmission member.
54. A system as in claim 30, further comprising a guidewire tube
extending through at least a portion of the catheter body for
allowing passage of a guidewire.
55. A system as in claim 36, wherein a sidewall of the guidewire
tube includes a plurality of apertures for allowing fluid
introduced into the lumen of the catheter body to pass into and
through the guidewire tube.
56. A system as in claim 41, wherein at least a portion of the
proximal housing comprises a material adapted to change color when
the temperature of the housing changes.
57. A system as in claim 56, wherein the material comprises a
thermochromic pigment.
58. A system as in claim 57, wherein the thermochromic pigment
changes from a first color to a second color when the temperature
of the housing reaches approximately 45.degree. Celsius and changes
from the second color to the first color when the temperature of
the housing drops below approximately 45.degree. Celsius.
59. A method for disrupting an occlusion in a blood vessel, the
method comprising: positioning an ultrasound catheter in the blood
vessel such that a distal end of the catheter is adjacent the
occlusion; transmitting ultrasound energy to an ultrasound
transmission member of the ultrasound catheter to disrupt the
occlusion into multiple occlusion fragments; and passing a cooled
irrigation fluid through the ultrasound catheter to dissipate heat
away from the ultrasound transmission member.
60. A method as in claim 59, wherein the cooled fluid has a
temperature between 1.degree. C. and 22.degree. C.
61. A method as in claim 59, wherein the cooled fluid is selected
from the group consisting of saline, thrombolytic agents,
antiplatelet drugs, lysing agents and anticoagulants.
62. A method as in claim 59, further comprising cooling the
irrigation fluid to a desired temperature, using a refrigeration
device coupled with the ultrasound catheter.
63. A method as in claim 59, wherein the cooled fluid is passed
continuously through the ultrasound catheter during an occlusion
disruption procedure.
64. A method as in claim 59, wherein the cooled fluid is passed
through the ultrasound catheter while the catheter is activated and
fluid passage is automatically stopped when the ultrasound catheter
is deactivated.
65. A method for disrupting an occlusion in a blood vessel, the
method comprising: positioning an ultrasound catheter in the blood
vessel such that a distal end of the catheter is adjacent the
occlusion; transmitting ultrasound energy to an ultrasound
transmission member of the ultrasound catheter to disrupt the
occlusion into multiple occlusion fragments; and passing an oxygen
supersaturated irrigation fluid through the ultrasound catheter to
dissipate heat away from the ultrasound transmission member.
66. A method as in claim 65, wherein the oxygen supersaturated
irrigation fluid comprises oxygen supersaturated saline
solution.
67. A method as in claim 65, wherein the oxygen supersaturated
irrigation fluid comprises saline solution combined with a
radiopaque contrast material.
68. A method as in claim 65, wherein the oxygen supersaturated
irrigation fluid has a temperature approximately the same as a room
temperature.
69. A method as in claim 65, wherein the oxygen supersaturated
irrigation fluid has a temperature between 1.degree. C. and
22.degree. C.
70. A method for disrupting an occlusion in a blood vessel, the
method comprising: positioning an ultrasound catheter in the blood
vessel such that a distal end of the catheter is adjacent the
occlusion; transmitting ultrasound energy to an ultrasound
transmission member of the ultrasound catheter to disrupt the
occlusion into multiple occlusion fragments; and passing a
lubricious irrigation fluid through the ultrasound catheter to
dissipate heat away from the ultrasound transmission member and
reduce friction between the ultrasound transmission member and an
ultrasound catheter body.
71. A method as in claim 70, wherein the lubricious irrigation
fluid comprises an emulsion.
72. A method as in claim 71, wherein the emulsion comprises olive
oil, egg yolk, phospholipids, glycerin, sodium deoxycholate,
L-histidine, disodium CDTA, sodium hydroxide and water.
73. A method as in claim 71, wherein the emulsion has a pH of
between 8.0 and 9.0.
74. A method as in claim 70, wherein the lubricious irrigation
fluid has a temperature approximately the same as a room
temperature.
75. A method as in claim 70, wherein the lubricious irrigation
fluid has a temperature between 1.degree. C. and 22.degree. C.
Description
[0001] This application is related to the following U.S. Patent
Application Serial Nos.: Ser. No. 10/229,371, filed Aug. 26, 2002,
entitled "Ultrasound Catheter for Disrupting Blood Vessel
Obstructions" (Attorney Docket No. 021577-000400US); Ser. No.
10/345,078, filed Jan. 14, 2003, entitled "Ultrasound Catheter and
Methods for Making and Using Same" (Attorney Docket No.
021577-000600US); Ser. No. 10/375,903, filed Feb. 26, 2003,
entitled "Ultrasound Catheter Apparatus" (Attorney Docket No.
021577-000700US); Ser. No. 10/410,617, filed Apr. 8, 2003, entitled
"Improved Ultrasound Catheter Devices and Methods" (Attorney Docket
No. 021577-000800US); and Ser. No. 10/722,209, filed Nov. 24, 2003,
entitled "Steerable Ultrasound Catheter" (Attorney Docket No.
021577-000900US). The full disclosures of all of the above-listed
patent applications are all hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to medical devices
and methods. More specifically, the present invention relates to
ultrasound catheter devices and methods for treating occlusive
intravascular lesions.
[0003] Catheters employing various types of ultrasound transmitting
members have been successfully used to ablate or otherwise disrupt
obstructions in blood vessels. Specifically, ablation of
atherosclerotic plaque or thromboembolic obstructions from
peripheral blood vessels such as the femoral arteries has been
particularly successful. Various ultrasonic catheter devices have
been developed for use in ablating or otherwise removing
obstructive material from blood vessels. For example, U.S. Pat.
Nos. 5,267,954 and 5,380,274, issued to an inventor of the present
invention and hereby incorporated by reference, describe ultrasound
catheter devices for removing occlusions. Other examples of
ultrasonic ablation devices for removing obstructions from blood
vessels include those described in U.S. Pat. No. 3,433,226 (Boyd),
U.S. Pat. No. 3,823,717 (Pohlman, et al.), U.S. Pat. No. 4,808,153
(Parisi), U.S. Pat. No. 4,936,281 (Stasz), U.S. Pat. No. 3,565,062
(Kuris), U.S. Pat. No. 4,924,863 (Sterzer), U.S. Pat. No. 4,870,953
(Don Michael, et al), and U.S. Pat. No. 4,920,954 (Alliger, et
al.), as well as other patent publications WO87-05739 (Cooper),
WO89-06515 (Bernstein, et al.), WO90-0130 (Sonic Needle Corp.),
EP316789 (Don Michael, et al.), DE3,821,836 (Schubert) and
DE2438648 (Pohlman). While many ultrasound catheters have been
developed, however, improvements are still being pursued.
[0004] Typically, an ultrasonic catheter system for ablating
occlusive material includes three basic components: an ultrasound
generator, an ultrasound transducer, and an ultrasound catheter.
The generator converts line power into a high frequency current
that is delivered to the transducer. The transducer contains
piezoelectric crystals which, when excited by the high frequency
current, expand and contract at high frequency. These small,
high-frequency expansions (relative to an axis of the transducer
and the catheter) are amplified by the transducer horn into
vibrational energy. The vibrations are then transmitted from the
transducer through the ultrasound catheter via an ultrasound
transmission member (or wire) running longitudinally through the
catheter. The transmission member transmits the vibrational energy
to the distal end of the catheter where the energy is used to
ablate or otherwise disrupt a vascular obstruction.
[0005] To effectively reach various sites for treatment of
intravascular occlusions, ultrasound catheters of the type
described above typically have lengths of about 150 cm or longer.
To permit the advancement of such ultrasound catheters through
small and/or tortuous blood vessels such as the aortic arch,
coronary vessels, and peripheral vasculature of the lower
extremities, the catheters (and their respective ultrasound
transmission wires) must typically be sufficiently small and
flexible. Also, due to attenuation of ultrasound energy along the
long, thin, ultrasound transmission wire, a sufficient amount of
vibrational energy must be applied at the proximal end of the wire
to provide a desired amount of energy at the distal end.
[0006] One continuing challenge in developing ultrasound catheters
for treating vascular occlusions is to provide adequate vibrational
energy at the distal end of a catheter device without overheating
the ultrasound transmission wire. Generally, increasing the amount
of power input to the ultrasound transmission wire causes the
temperature of the wire to increase. Overheating may occur anywhere
along the length of the transmission wire, from its proximal
connection with the ultrasound transducer to the distal tip of the
wire. Overheating of the wire, along with the mechanical stresses
placed on the wire from propagating ultrasound waves, can cause
wire breakage, thus shortening the useful life of the catheter
device. Furthermore, it is generally desirable to ablate an
occlusion via the ultrasound vibrations and not by heating the
occlusion, since heating causes a denaturalization process that
reduces the efficacy of the ultrasound ablation.
[0007] Some ultrasound catheters use irrigation fluid to attempt to
control the temperature of the ultrasound transmission wire, but
such irrigation cooling techniques are not always effective. Other
devices use swapped frequencies to change frequency nodes and
anti-nodes, thus moving a heat source from point to point along the
transmission wire. However, a given ultrasound transmission wire
resonates at the fundamental frequency for which it is designed,
and thus changing frequencies essentially requires turning the
ultrasound device on and off, which reduces the efficacy of the
device. Some ultrasound catheter devices include one or more
absorption members at the proximal end for absorbing unwanted
vibrations of the ultrasound transmission wire. Such absorbers,
however, do not address the heat generation issue and, in fact, may
cause increased heating from frictional forces.
[0008] Therefore, a need exists for improved ultrasound catheter
devices and methods that provide ablation or disruption of vascular
occlusions. Ideally, such ultrasound catheters would provide a
desired level of power at a distal end of the device while also
preventing overheating of the device's ultrasound transmission
member. Ideally, such devices would address ultrasound transmission
wire overheating at its proximal connection with a catheter device
as well as along the length of the wire. At least some of these
objectives will be met by the present invention.
BRIEF SUMMARY OF THE INVENTION
[0009] In one aspect of the invention, an ultrasound catheter for
disrupting occlusions in blood vessels includes: an elongate
flexible catheter body having a proximal end, a distal end and at
least one lumen; an ultrasound transmission member extending
longitudinally through the lumen of the catheter body and having a
proximal end and a distal end; a distal head coupled with the
distal end of the ultrasound transmission member and disposed
adjacent the distal end of the catheter body; a sonic connector
coupled with the proximal end of the ultrasound transmission member
for coupling the ultrasound transmission member with an ultrasound
transducer device; and a proximal housing coupled with the proximal
end of the catheter body and housing the sonic connector and a
proximal portion of the ultrasound transmission wire. The proximal
housing includes at least one heat dissipation feature for
dissipating heat from the proximal portion of the ultrasound
transmission member.
[0010] In some embodiments, the heat dissipation feature comprises
one or more portions of the housing constructed of a heat
conductive material. For example, the heat conductive material may
include, but is not limited to, metal, polymer, glass, rubber,
combinations thereof, or the like. Additionally (or alternatively),
the heat dissipation feature may comprise multiple surface features
on the housing to increase a surface area of the housing. Such
surface features may include, for example, grooves, notches, waves,
dips and/or the like. In some embodiments, an additional or
alternative heat dissipation feature comprises at least one
conductive material disposed within the housing, at least partially
encircling the ultrasound transmission member, to conduct heat away
from the ultrasound transmission member. In one embodiment, the
conductive material may be disposed adjacent one or more vibration
absorption members surrounding the ultrasound transmission member.
Optionally, multiple separate conductive members may be disposed
between multiple vibration absorption members to at least partially
encircle the ultrasound transmission member. In another embodiment,
the conductive material is arranged over one or more vibration
absorption members surrounding the ultrasound transmission
member.
[0011] In some embodiments, the heat dissipation feature comprises
at least one fluid inlet for allowing passage of one or more heat
dissipating fluids into an inner cavity of the housing. In some
embodiments, the inner cavity of the housing is in fluid
communication with the lumen of the catheter body, such that fluid
introduced into the inner cavity passes through and out a distal
end of the catheter body lumen. In some embodiments, the inlet is
disposed along the housing such that the heat dissipating fluid(s)
passing through the inlet contact at least one vibration absorption
member disposed over the ultrasound transmission member. The inlet
may also be disposed along the housing such that the heat
dissipating fluid(s) passing through the inlet contact the sonic
connector and a portion of the ultrasound transmission member. Some
devices further include a refrigeration device coupled with the
catheter for refrigerating a fluid to be introduced through the
fluid inlet. Optionally, the device may further include a guidewire
tube extending through at least a portion of the catheter body for
allowing passage of a guidewire. In one embodiment, a sidewall of
the guidewire tube includes a plurality of apertures for allowing
fluid introduced into the lumen of the catheter body to pass into
and through the guidewire tube.
[0012] In some embodiments, at least a portion of the proximal
housing comprises a material adapted to change color when the
temperature of the housing changes. In one embodiment, for example,
the material comprises a thermochromic pigment. The thermochromic
pigment, in one embodiment, may change from a first color to a
second color when the temperature of the housing reaches
approximately 45.degree. Celsius and changes from the second color
to the first color when the temperature of the housing drops below
approximately 45.degree. Celsius.
[0013] In another aspect of the present invention, an ultrasound
catheter for disrupting occlusions in blood vessels includes: an
elongate flexible catheter body having a proximal end, a distal end
and at least one lumen; an ultrasound transmission member extending
longitudinally through the lumen of the catheter body and having a
proximal end and a distal end; a distal head coupled with the
distal end of the ultrasound transmission member and disposed
adjacent the distal end of the catheter body; a sonic connector
coupled with the proximal end of the ultrasound transmission member
for coupling the ultrasound transmission member with an ultrasound
transducer device; a proximal housing coupled with the proximal end
of the catheter body and housing the sonic connector and a proximal
portion of the ultrasound transmission wire; and heat dissipation
means for dissipating heat from the ultrasound transmission member.
According to various embodiments, heat dissipation means may
include any suitable members, devices, attachments or the likes,
such as but not limited to those described above. Any features
described above may be applied to this ultrasound catheter.
[0014] In another aspect of the present invention, an ultrasound
catheter system for disrupting occlusions in blood vessels includes
an ultrasound catheter device, an ultrasound generator removably
coupled with the ultrasound catheter device, and a fluid cooling
device removably coupled with the ultrasound catheter device for
cooling one or more heat dissipating fluids to be passed through
the catheter device. The ultrasound catheter device itself
includes: an elongate flexible catheter body having a proximal end,
a distal end and at least one lumen; an ultrasound transmission
member extending longitudinally through the lumen of the catheter
body and having a proximal end and a distal end; a distal head
coupled with the distal end of the ultrasound transmission member
and disposed adjacent the distal end of the catheter body; a sonic
connector coupled with the proximal end of the ultrasound
transmission member for coupling the ultrasound transmission member
with an ultrasound transducer device; and a proximal housing
coupled with the proximal end of the catheter body and housing the
sonic connector and a proximal portion of the ultrasound
transmission wire. The housing includes at least one fluid inlet
for allowing passage of one or more heat dissipating fluids into an
inner cavity of the housing. Again, the ultrasound catheter may
include any of the features described above.
[0015] In another aspect of the present invention, a method for
disrupting an occlusion in a blood vessel involves positioning an
ultrasound catheter in the blood vessel such that a distal end of
the catheter is adjacent the occlusion; transmitting ultrasound
energy to an ultrasound transmission member of the ultrasound
catheter to disrupt the occlusion into multiple occlusion
fragments, and passing a cooled irrigation fluid through the
ultrasound catheter to dissipate heat away from the ultrasound
transmission member. In some embodiments, for example, the cooled
fluid has a temperature between about 1.degree. C. and about
22.degree. C. Any suitable cooled fluid may be used, such as but
not limited to saline, thrombolytic agents, antiplatelet drugs,
lysing agents, anticoagulants and/or the like. In some embodiments,
the method further involves cooling the irrigation fluid to a
desired temperature, using a refrigeration device coupled with the
ultrasound catheter. In one embodiment, cooled fluid is passed
continuously through the ultrasound catheter during an occlusion
disruption procedure. Alternatively, the cooled fluid may be passed
through the ultrasound catheter while the catheter is activated,
with fluid passage being automatically stopped when the ultrasound
catheter is deactivated.
[0016] In another aspect of the present invention, a method for
disrupting an occlusion in a blood vessel involves positioning an
ultrasound catheter in the blood vessel such that a distal end of
the catheter is adjacent the occlusion, transmitting ultrasound
energy to an ultrasound transmission member of the ultrasound
catheter to disrupt the occlusion into multiple occlusion
fragments, and passing an oxygen supersaturated irrigation fluid
through the ultrasound catheter to dissipate heat away from the
ultrasound transmission member. In some embodiments, for example,
the oxygen supersaturated irrigation fluid comprises oxygen
supersaturated saline solution. In other embodiments, the oxygen
supersaturated irrigation fluid comprises saline solution combined
with a radiopaque contrast material. The oxygen supersaturead fluid
may be kept at any suitable temperature. In some embodiments, the
fluid is kept at room temperature, while in other embodiments it is
kept at between about 1.degree. C. and about 22.degree. C.
[0017] In another aspect of the present invention, a method for
disrupting an occlusion in a blood vessel involves positioning an
ultrasound catheter in the blood vessel such that a distal end of
the catheter is adjacent the occlusion, transmitting ultrasound
energy to an ultrasound transmission member of the ultrasound
catheter to disrupt the occlusion into multiple occlusion
fragments, and passing a lubricious irrigation fluid through the
ultrasound catheter to dissipate heat away from the ultrasound
transmission member and reduce friction between the ultrasound
transmission member and an ultrasound catheter body. For example,
in some embodiments, the lubricious irrigation fluid comprises an
emulsion. In one embodiment, the emulsion comprises olive oil, egg
yolk, phospholipids, glycerin, sodium deoxycholate, L-histidine,
disodium CDTA, sodium hydroxide and water. In some embodiments, the
emulsion has a pH of between about 8.0 and about 9.0. The
lubricious fluid may be kept at any suitable temperature. In some
embodiments, the fluid is kept at room temperature, while in other
embodiments it is kept at between about 1.degree. C. and about
22.degree. C.
[0018] These and other aspects and embodiments of the present
invention are described in further detail below, in reference to
the attached drawing figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a perspective view of an ultrasound catheter
system according to an embodiment of the present invention;
[0020] FIG. 2 is a side view of an ultrasound catheter device
according to an embodiment of the present invention;
[0021] FIG. 3 is cross-sectional side view of a proximal portion of
an ultrasound catheter device having heat dissipation means
according to an embodiment of the present invention;
[0022] FIG. 4 is cross-sectional side view of a proximal portion of
an ultrasound catheter device having heat dissipation means
according to another embodiment of the present invention;
[0023] FIG. 5 is cross-sectional side view of a proximal portion of
an ultrasound catheter device having heat dissipation means
according to another embodiment of the present invention;
[0024] FIG. 6 is cross-sectional side view of a proximal portion of
an ultrasound catheter device, with a proximal housing of the
device having a fluid inlet aperture according to an embodiment of
the present invention;
[0025] FIG. 7 is cross-sectional side view of a proximal portion of
an ultrasound catheter device, with a proximal housing of the
device having a fluid inlet aperture according to another
embodiment of the present invention; and
[0026] FIG. 8 is a cross-sectional side view of a distal portion of
an ultrasound catheter device having a perforated guidewire tube
for allowing passage of fluid therethrough according to another
embodiment of the present invention
DETAILED DESCRIPTION OF THE INVENTION
[0027] Ultrasound catheter devices and methods of the present
invention provide for disruption of occlusions in blood vessels.
Catheter devices generally include a catheter body, an ultrasound
energy transmission member disposed within the catheter body and a
distal head coupled with the energy transmission member and
disposed at or near the distal end of the catheter body. The
ultrasound transmission member transmits ultrasound energy from an
ultrasound transducer to the distal head, causing the head to
vibrate and, thus, disrupt vascular occlusions. A number of
improved features of such ultrasound catheter devices are described
more fully below.
[0028] Referring now to FIG. 1, one embodiment of an ultrasound
catheter system 20 suitably includes an ultrasound catheter device
10 and an ultrasound generator 16. Catheter device 10 suitably
includes a distal head 26 for disrupting occlusions, a catheter
body 27, and a proximal end connector 12 for coupling catheter
device 10 with an ultrasound transducer 14. Ultrasound transducer
14 is coupled with ultrasound generator 16 via a connector 28, and
generator is coupled with a foot-actuated on/off switch 18 via
another connector 29. Generator 16 provides ultrasonic energy to
transducer 14 and, thus, to ultrasound catheter 10. Catheter device
10 further includes an ultrasound transmission member (or
"wire"--not shown) that extends through the catheter body 27 and
transmits energy from the transducer 14 to the distal head 26. Some
embodiments of device 10 include a rapid exchange guidewire 13 and
guidewire port, while other embodiments include a proximal
guidewire port for over the wire guidewire delivery. In some
embodiments, transducer 14 further includes a securing device 15
for enhancing coupling of catheter 10 to transducer 14. The various
components of system 20 may be coupled via any suitable means.
Connectors 28, 29 may comprise an electric cord or cable or any
other suitable connecting devices for coupling on/off switch 18,
generator 16 and transducer 14. In an alternative embodiment,
on/off swith 18 is located on generator 16.
[0029] In addition to proximal connector 12, ultrasound catheter
device 10 may include one or more other various components, such as
a Y-connector 11 including a fluid inlet port 17 (or aperture) for
passage of irrigation fluid. Inlet port 17 may be removably coupled
with an irrigation tube 24, which in one embodiment may be coupled
with a fluid refrigeration (or "fluid cooling") device 30.
Refrigeration device 30 may, in turn, be coupled with a fluid
container 32 via a connector tube 34. This irrigation apparatus may
be used for introducing one or more fluids into catheter device 10.
Fluid may be used to cool any part of the device, such as the
ultrasound transmission member, thus helping reduce wear and tear
of device 10. In some embodiments, fluid inlet port 17 is located
farther proximally on proximal connector 12, to allow fluid to be
applied within connector 12. In some embodiments, refrigerated
fluid is used, while in other embodiments irrigation fluid may be
kept at room temperature. In various embodiments, oxygen
supersaturated fluid, lubricious fluid, or any other suitable fluid
or combination of fluids may be used, and again, such fluids may be
refrigerated or kept room temperature. In an alternative embodiment
to that shown in FIG. 1, refrigeration device 30 and fluid
container 32 are combined in one device.
[0030] Generally, catheter device 10 may include any suitable
number of side-arms or ports for passage of a guidewire,
application of suction, infusing and/or withdrawing irrigation
fluid, dye and/or the like, or any other suitable ports or
connections. Also, ultrasound catheters 10 of the present invention
may be used with any suitable proximal devices, such as any
suitable ultrasound transducer 14, ultrasound generator 16,
coupling device(s) and/or the like. Therefore, the exemplary
embodiment shown in FIG. 1 and any following descriptions of
proximal apparatus or systems for use with ultrasound catheters 10
should not be interpreted to limit the scope of the present
invention as defined in the appended claims.
[0031] Referring now to FIG. 2, an enlarged view of catheter device
10 is shown. Proximal connector 12, Y-connector 11, inlet port 17,
catheter body 27, distal head 26 and guidewire 13 are all shown.
Catheter body 27 is generally a flexible, tubular, elongate member,
having any suitable diameter and length for reaching a vascular
occlusion for treatment. In one embodiment, for example, catheter
body 27 preferably has an outer diameter of between about 0.5 mm
and about 5.0 mm. In other embodiments, as in catheters intended
for use in relatively small vessels, catheter body 27 may have an
outer diameter of between about 0.25 mm and about 2.5 mm. Catheter
body 27 may also have any suitable length. As discussed briefly
above, for example, some ultrasound catheters have a length in the
range of about 150 cm. However, any other suitable length may be
used without departing from the scope of the present invention.
Examples of catheter bodies similar to those which may be used in
the present invention are described in U.S. Pat. Nos. 5,267,954 and
5,989,208, which were previously incorporated herein by
reference.
[0032] Features of the present invention may be applied to any of a
number of ultrasound catheter devices. For more detailed
description of exemplary ultrasound catheter devices, reference may
be made to U.S. patent application Ser. Nos. 10/229,371,
10/345,078, 10/375,903, 10/410,617 and 10/722,209, which were all
previously incorporated by reference. In various alternative
embodiments, aspects of the present invention may be applied to any
other suitable catheter devices.
[0033] Referring now to FIG. 3, a proximal portion of one
embodiment of an ultrasound catheter device 110 is shown in
cross-section. An ultrasound transmission wire 140 extends from a
sonic connector 152 distally to a distal end (not shown) of
catheter device 110. A catheter body 127 of device 110 is shown
only in part, whereas catheter body 127 typically extends distally
to (or near) the distal end of device 110. Catheter device 110 also
includes a proximal housing 112 (or "proximal connector"), having
an inner bore 144 (or "inner cavity") in which sonic connector 152,
a portion of ultrasound transmission member 140 and one or more
vibration absorption members 150 reside. Housing 112 is coupled
with a Y-connector 111, which includes a fluid inlet port 117 (or
aperture), and Y-connector 111 is coupled with catheter body
127.
[0034] In various embodiments, housing 112 may suitably include one
or more surface features 142 for increasing the overall surface
area of the outer surface of housing 112. Increased surface area
enhances the ability of housing 112 to dissipate heat generated by
ultrasound transmission member 140 out of catheter device 110.
Surface features 142 may have any suitable size or shape, such as
ridges, jags, undulations, grooves or the like, and any suitable
number of surface features 142 may be used. Additionally, housing
112 may be made of one or more heat dissipating materials, such as
aluminum, stainless steel, any other conductive metal(s), or any
suitable non-metallic conductive material(s).
[0035] In most embodiments, ultrasound transmission member 140,
wire, or wave guide extends longitudinally through a lumen of
catheter body 127 to transmit ultrasonic energy from an ultrasound
transducer (not shown), connected to the proximal end of proximal
housing 112, to the distal end of catheter device 110. Ultrasound
transmission member 140 may be formed of any material capable of
effectively transmitting ultrasonic energy from the ultrasound
transducer to the distal end of catheter body 127, including but
not limited to metals such as pure titanium or aluminum, or
titanium or aluminum alloys. Again, additional details of
ultrasound transmission members 140 may be found in the patent
applications incorporated by reference above. Similarly, reference
may be made to the incorporated patent applications for
descriptions of housing 112, sonic connector 152, vibration
absorption members 150, Y-connector 111 and the like. For example,
housing 112 and other features are described in detail in Ser. No.
10/722,209, filed Nov. 24, 2003, entitled "Steerable Ultrasound
Catheter" (Attorney Docket No. 021577-000900US), which was
previously incorporated by reference.
[0036] Ultrasound transmission member 140 typically passes from
sonic connector 152, through bore 144 and Y-connector 111, and then
through catheter body 127. Fluid inlet port 117 is in fluid
communication with a lumen in Y-connector, which is in fluid
communication with a lumen extending through catheter body 127.
Thus, fluid introduced into fluid inlet port 117 is typically free
to flow into and through catheter body 127 to contact ultrasound
transmission member 140. Fluid may flow out of catheter body 127
through apertures in the distal head (not shown) or through any
other suitable apertures or openings, such as apertures located in
catheter body 127 itself. Any suitable fluid may be passed through
fluid inlet port 117 and catheter body 127, such as refrigerated
fluid, lubricious fluid, super-saturated saline or contrast/saline
mixture, or the like. Cooling and/or lubricating ultrasound
transmission member 140 may reduce friction and/or wear and tear of
ultrasound transmission member 140, thus prolonging the useful life
of ultrasound catheter device 110 and enhancing its
performance.
[0037] Additionally, the temperature and flow rate of a coolant
liquid may be specifically controlled to maintain the temperature
of ultrasound transmission member 140 at a desired temperature
within its optimal working range. In particular, in embodiments of
the invention where ultrasound transmission member 140 is formed of
a metal alloy which exhibits optimal physical properties (e.g.
super elasticity) within a specific range of temperatures, the
temperature and flow rate of coolant liquid infused through fluid
inlet port 117 may be specifically controlled to maintain the
temperature of ultrasound transmission member 140 within a range of
temperatures at which it demonstrates its most desirable physical
properties. For example, in embodiments of the invention where
ultrasound transmission member 140 is formed of a shape memory
alloy which exhibits super-elasticity when in its martensite state,
but which loses super-elasticity as it transitions to an austenite
state, it will be desirable to adjust the temperature and flow rate
of the coolant liquid infused through fluid inlet port 117 to
maintain the shape memory alloy of ultrasound transmission member
140 within a temperature range at which the alloy will remain in
its martensite state and will not transition to an austenite state.
The temperature at which such shape memory alloys transition from a
martensite state to an austenite state is known as the "martensite
transition temperature" of the material. Thus, in these
embodiments, the fluid infused through port 117 will be at such
temperature, and will be infused at such rate, as to maintain the
shape memory alloy of ultrasound transmission member 140 below its
martensite transition temperature.
[0038] As mentioned above, in one embodiment, a super-saturated
fluid may be used. Use of such fluids may enhance cavitation of an
occlusion, help prevent unwanted tissue damage and/or the like.
Such fluids are described, for example, in U.S. Pat. Nos.
6,676,900, 6,622,542, 6,613,280, 6,607,698, 6,605,217, 6,602,468,
6,602,467, 6,596,235, 6,582,387, 6,576,807, 6,558,502, 6,555,059,
6,533,766, 6,454,997, 6,387,324, 6,346,192, 6,315,754, 6,248,087,
6,235,007, 6,180,059, 6,142,971, 6,123,698, 6,030,357, 5,976,119,
5,957,889, 5,893,838 and 5,797,876, which are hereby incorporated
by reference. In another embodiment, a mixture of contrast dye and
saline may be used to achieve the same or similar results.
[0039] With reference now to FIG. 4, one embodiment of an
ultrasound catheter device 210 includes the features described
immediately above and also includes a heat absorbing member 160
disposed within housing 112. Heat absorbing member 160 may have any
suitable shape and size and may, in various embodiments, be
disposed in any of a number of different locations within housing
112. Typically, heat absorbing member 160 is made of a heat
absorbing material, such as but not limited to a metalized
elastomer, such as a rubber material combined with a metallic
powder such as aluminum powder. Of course, any other suitable heat
sink or heat absorption material may be used, in alternative
embodiments. In the embodiment shown, heat absorbing member 160 is
generally cylindrical in shape and is disposed around vibration
absorption members 150, so that it absorbs heat from ultrasound
transmission member 140 and vibration absorbers 150.
[0040] Referring to FIG. 5, in an alternative embodiment an
ultrasound catheter device 310 may include multiple heat absorption
members 170, such as cylindrical members disposed around ultrasound
transmission member 140 and in between multiple vibration
absorption members 150. As is evident from FIGS. 4 and 5, any of a
number of configurations of heat absorption members 160, 170 may be
disposed within housing 112.
[0041] FIG. 6 demonstrates another embodiment of an ultrasound
catheter device 410, which may include any of the features
described above. In this embodiment, a fluid inlet port 217 is
located farther proximally on housing 112 than in the
earlier-described embodiments. Fluid inlet port 217 is in fluid
communication with inner cavity 144 of housing 112, so that fluid
(solid-tipped arrows) introduced into fluid inlet port 217 enters
inner cavity 144 and contacts vibration absorption members 150
before entering the lumen of catheter body 127 via one or more
proximal apertures 220. Fluid passing along and contacting
vibration absorption members 150 will help dissipate heat from the
members 150. As mentioned above, such fluids may be
refrigerated/cooled, lubricious, oxygen supersaturated or the like.
Lubricious and oxygen supersaturated fluids, in various
embodiments, may be either cooled/refrigerated or at room
temperature.
[0042] Referring to FIG. 7, another embodiment of an ultrasound
catheter device 510 includes all the features just described, but
fluid inlet port 317 is located farther proximally on housing 112.
In this embodiment, fluid (solid-tipped arrows) entering fluid
inlet port 317 contacts a proximal portion of ultrasound
transmission member 140, proceeds distally to contact vibration
absorption members 150, and then proceeds through apertures 220
into the lumen of catheter body 127. Thus, the fluid provides extra
heat dissipation to the proximal portion of ultrasound transmission
member 140 with which it comes in contact.
[0043] As mentioned above, in some embodiments irrigation/cooling
fluid passes through a lumen of catheter body 127 and out one or
more apertures in distal head 26 or elsewhere on the catheter
device. In an alternative embodiment, and with reference now to
FIG. 8, an ultrasound catheter device 610 may include a guidewire
tube 424 that forms a guidewire lumen 426 and that includes one or
more guidewire tube apertures 430 for allowing passage of fluid.
Generally, a guidewire 420 may be passed through guidewire lumen
426 and out a distal aperture 422 of guidewire tube 424, located in
distal head 26. Fluid (solid-tipped arrows) that is passed through
a catheter body lumen 428 may flow into apertures 430 and out
distal aperture 422. The fluid would thus contact ultrasound
transmission member 140 during a portion of its journey through
catheter body lumen 428, thus dissipating heat and/or lubricating,
and would then pass out of catheter device 610 via guidewire tube
424. This configuration may be advantageous in that irrigation
fluid may provide an additional lubrication inside guidewire lumen
426 to improve guidewire movement.
[0044] In one embodiment, housing 112 may include a material that
changes color when its temperature increases or decreases, thus
providing an indication of the temperature of the proximal portion
of the catheter device. In one embodiment, for example, a
thermochromic material, such as Colorcomp.RTM. Thermochromics
(provided by LNP Engineering Plastics, Inc.) may be used. Other
color-change materials may be used in alternative embodiments. In
various embodiments, the color of such material may change at any
suitable temperatures. In one embodiment, for example, the
thermochromic pigment changes from a first color to a second color
when the temperature of housing 112 reaches approximately
45.degree. Celsius and changes from the second color to the first
color when the temperature of housing 112 drops below approximately
45.degree. Celsius.
[0045] Although the invention has been described above with
specific reference to various embodiments and examples, it should
be understood that various additions, modifications, deletions and
alterations may be made to such embodiments without departing from
the spirit or scope of the invention. Accordingly, it is intended
that all reasonably foreseeable additions, deletions, alterations
and modifications be included within the scope of the invention as
defined in the following claims.
* * * * *